Tissue fixation devices and assemblies for deploying the same

ABSTRACT

Tissue fasteners carried on a tissue piercing deployment wire fasten tissue layers of a mammalian body together include a first member, a second member, and a connecting member extending between the first and second members. One of the first and second members has an elongated slot permitting fastener deployment while avoiding excessive tissue compression.

RELATED APPLICATION DATA

This application is a division of U.S. Ser. No. 12/590,203 filed Nov. 4,2009, now U.S. Pat. No. 8,911,473, which is a continuation of U.S. Ser.No. 10/949,737 filed Sep. 23, 2004, now U.S. Pat. No. 7,623,287, whichis a continuation-in-part application of U.S. Ser. No. 10/783,717 filedFeb. 20, 2004, now abandoned.

FIELD OF THE INVENTION

The present invention generally relates to tissue fixation devices, andmore particularly to devices for treating gastroesophageal refluxdisease using the same. The present invention more particularly relatesto such tissue fixation devices which may be used in surgicalenvironments and which are self-deploying.

BACKGROUND

Gastroesophageal reflux disease (GERD) is a chronic condition caused bythe failure of the anti-reflux barrier located at the gastroesophagealjunction to keep the contents of the stomach from splashing into theesophagus. The splashing is known as gastroesophageal reflux. Thestomach acid is designed to digest meat, and will digest esophagealtissue when persistently splashed into the esophagus.

A principal reason for regurgitation associated with GERD is themechanical failure of a deteriorated gastroesophageal flap to close andseal against high pressure in the stomach. Due to reasons includinglifestyle, a Grade I normal gastroesophageal flap may deteriorate into amalfunctioning Grade III or absent valve Grade IV gastroesophageal flap.With a deteriorated gastroesophageal flap, the stomach contents are morelikely to be regurgitated into the esophagus, the mouth, and even thelungs. The regurgitation is referred to as “heartburn” because the mostcommon symptom is a burning discomfort in the chest under thebreastbone. Burning discomfort in the chest and regurgitation (burpingup) of sour-tasting gastric juice into the mouth are classic symptoms ofgastroesophageal reflux disease (GERD). When stomach acid isregurgitated into the esophagus, it is usually cleared quickly byesophageal contractions. Heartburn (backwashing of stomach acid and bileonto the esophagus) results when stomach acid is frequently regurgitatedinto the esophagus and the esophageal wall is inflamed.

Complications develop for some people who have GERD. Esophagitis(inflammation of the esophagus) with erosions and ulcerations (breaks inthe lining of the esophagus) can occur from repeated and prolonged acidexposure. If these breaks are deep, bleeding or scarring of theesophagus with formation of a stricture (narrowing of the esophagus) canoccur. If the esophagus narrows significantly, then food sticks in theesophagus and the symptom is known as dysphagia. GERD has been shown tobe one of the most important risk factors for the development ofesophageal adenocarcinoma. In a subset of people who have severe GERD,if acid exposure continues, the injured squamous lining is replaced by aprecancerous lining (called Barrett's Esophagus) in which a cancerousesophageal adenocarcinoma can develop.

Other complications of GERD may not appear to be related to esophagealdisease at all. Some people with GERD may develop recurrent pneumonia(lung infection), asthma (wheezing), or a chronic cough from acidbacking up into the esophagus and all the way up through the upperesophageal sphincter into the lungs. In many instances, this occurs atnight, while the person is in a supine position and sleeping.Occasionally, a person with severe GERD will be awakened from sleep witha choking sensation. Hoarseness can also occur due to acid reaching thevocal cords, causing a chronic inflammation or injury.

GERD never improves without intervention. Life style changes combinedwith both medical and surgical treatments exist for GERD. Medicaltherapies include antacids and proton pump inhibitors. However, themedical therapies only mask the reflux. Patients still get reflux andperhaps emphysema because of particles refluxed into the lungs.Barrett's esophagus results in about 10% of the GERD cases. Theesophageal epithelium changes into tissue that tends to become cancerousfrom repeated acid washing despite the medication.

Several open laparotomy and laproscopic surgical procedures areavailable for treating GERD. One surgical approach is the Nissenfundoplication. The Nissen approach typically involves a 360-degree wrapof the fundus around the gastroesophageal junction. The procedure has ahigh incidence of postoperative complications. The Nissen approachcreates a 360-degree moveable flap without a fixed portion. Hence,Nissen does not restore the normal movable flap. The patient cannot burpbecause the fundus was used to make the repair, and may frequentlyexperience dysphagia. Another surgical approach to treating GERD is theBelsey Mark IV (Belsey) fundoplication. The Belsey procedure involvescreating a valve by suturing a portion of the stomach to an anteriorsurface of the esophagus. It reduces some of the postoperativecomplications encountered with the Nissen fundoplication, but still doesnot restore the normal movable flap. None of these procedures fullyrestores the normal anatomical anatomy or produces a normallyfunctioning gastroesophageal junction. Another surgical approach is theHill repair. In the Hill repair, the gastroesophageal junction isanchored to the posterior abdominal areas, and a 180-degree valve iscreated by a system of sutures. The Hill procedure restores the moveableflap, the cardiac notch and the Angle of His. However, all of thesesurgical procedures are very invasive, regardless of whether done as alaproscopic or an open procedure.

New, less surgically invasive approaches to treating GERD involvetransoral endoscopic procedures. One procedure contemplates a machinedevice with robotic arms that is inserted transorally into the stomach.While observing through an endoscope, an endoscopist guides the machinewithin the stomach to engage a portion of the fundus with acorkscrew-like device on one arm. The arm then pulls on the engagedportion to create a fold of tissue or radial plication at thegastroesophageal junction. Another arm of the machine pinches the excesstissue together and fastens the excess tissue with one pre-tied implant.This procedure does not restore normal anatomy. The fold created doesnot have anything in common with a valve. In fact, the direction of theradial fold prevents the fold or plication from acting as a flap of avalve.

Another transoral procedure contemplates making a fold of fundus tissuenear the deteriorated gastroesophageal flap to recreate the loweresophageal sphincter (LES). The procedure requires placing multipleU-shaped tissue clips around the folded fundus to hold it in shape andin place.

This and the previously discussed procedure are both highly dependent onthe skill, experience, aggressiveness, and courage of the endoscopist.In addition, these and other procedures may involve esophageal tissue inthe repair. Esophageal tissue is fragile and weak. Involvement ofesophageal tissue in the repair of a gastroesophageal flap valve posesunnecessary risks to the patient.

A new and improved apparatus and method for restoration of agastroesophageal flap valve is fully disclosed in copending U.S.application Ser. No. 10/150,740, filed May 17, 2002, for TRANSORALENDOSCOPIC GASTROESOPHAGEAL FLAP VALVE RESTORATION DEVICE, ASSEMBLY,SYSTEM AND METHOD, is assigned to the assignee of this invention, and isincorporated herein by reference. That apparatus and method provides atransoral endoscopic gastroesophageal flap valve restoration. Alongitudinal member arranged for transoral placement into a stomachcarries a tissue shaper that non-invasively grips and shapes stomachtissue. A tissue fixation device is then deployed to maintain the shapedstomach tissue in a shape approximating a gastroesophageal flap.

Whenever tissue is to be maintained in a shape as, for example, in theimproved assembly last mentioned above, it is necessary to fasten atleast two layers of tissue together. In applications such asgastroesophageal flap valve restoration, there is very limited room tomaneuver a fastener deployment device. For example, this and othermedical fastening applications provide confined working channels andspaces and often must be fed through an endoscope to permitvisualization or other small lumen guide catheters to the place wherethe fasteners are to be deployed. To make matters worse, multiplefasteners may also be required. Hence, with current fasteners anddeployment arrangements, it is often difficult to direct a singlefastener to its intended location, let alone a number of such fasteners.

Once the fastening site is located, the fasteners employed must be trulyable to securely maintain the tissue. Also, quite obviously, thefasteners are preferably deployable in the tissue in a manner which doesnot unduly traumatize the tissue.

SUMMARY

The present invention provides a fastener for use in a mammalian body,comprising a first member, a second member, the first and second membershaving first and second ends, and a connecting member fixed to each ofthe first and second members intermediate the first and second ends andextending between the first and second members. The first and secondmembers are separated by the connecting member, and one of the first andsecond members has a longitudinal axis, a through channel along the axisarranged to be slidingly received on a tissue piercing deployment wire,and an elongated slot communicating with the through channel anddimensioned to receive the tissue piercing deployment wire.

The invention further provides a fastener assembly for use in amammalian body, comprising a fastener including a first member, a secondmember, wherein the first and second members have first and second ends,and a connecting member fixed to each of the first and second membersintermediate the first and second ends and extending between the firstand second members, wherein the first and second members are separatedby the connecting member, and wherein one of the first and secondmembers has a longitudinal axis, a through channel along the axis, andan elongated slot communicating with the through channel. The assemblyfurther comprises a deployment wire arranged to be slidingly received bythe through channel and the elongated slot of the one of the first andsecond members and to pierce into the tissue, and a pusher that pushesthe one of first and second members into the tissue while on thedeployment wire.

The first member, second member, and the connecting member may all beformed of plastic material and in one piece.

The connecting member of the fastener may be formed of plastic elasticmaterial. Alternatively, the connecting member may be formed of aplastic, permanently deformable material. The plastic material mayinclude a color pigment contrasting with body tissue color to enablevisualization of the fastener with an endoscope.

One end of the one of the first and second members of the fastener mayfurther include a pointed tip. The pointed tip may comprise a truncatedcone. Alternatively, the pointed tip may comprise a sectioned portion.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention which are believed to be novel areset forth with particularity in the appended claims. The invention,together with further objects and advantages thereof, may best beunderstood by making reference to the following description taken inconjunction with the accompanying drawings, in the several figures ofwhich like referenced numerals identify like elements, and wherein:

FIG. 1 is a front cross-sectional view of theesophageal-gastro-intestinal tract from a lower portion of the esophagusto the duodenum;

FIG. 2 is a front cross-sectional view of theesophageal-gastro-intestinal tract illustrating a Grade I normalappearance movable flap of the gastroesophageal flap valve (in dashedlines) and a Grade III reflux appearance gastroesophageal flap of thegastroesophageal flap valve (in solid lines);

FIG. 3 is a perspective view of a fastener embodiment;

FIG. 4 is a perspective view of another fastener embodiment;

FIG. 5 is a perspective view with portions cut away of a fastenerassembly embodiment in an early stage of deploying a fastenerembodiment;

FIG. 6 is a perspective view of the assembly of FIG. 5 shown with thefastener being driven in the tissue layers to be fastened;

FIG. 7 is a perspective view of the assembly of FIG. 5 shown with thefastener extending through the tissue layers to be fastened;

FIG. 8 is a perspective view of the assembly of FIG. 5 shown with thefastener initially deployed;

FIG. 9 is a perspective view showing the fastener of the assembly ofFIG. 5 fully deployed and securely fastening a pair of tissue layerstogether;

FIG. 10 is a perspective view with portions cut away of another fastenerdeployment assembly embodiment in an early stage of deploying anotherfastener embodiment;

FIG. 11 is a perspective view with portions cut away of another fastenerdeployment assembly embodiment in an early stage of deploying anotherfastener embodiment;

FIG. 12 is a perspective view showing the fastener of the assembly ofFIG. 11 fully deployed and securely fastening a pair of tissue layerstogether;

FIG. 13 is a perspective view of another fastener embodiment;

FIG. 14 is a top plan view of the fastener of FIG. 13;

FIG. 15 is a perspective view of still another fastener embodiment;

FIG. 16 is a top plan view of the fastener of FIG. 15;

FIG. 17 is a perspective view of a fastener according to an embodimentof the invention;

FIG. 18 is a side view of the fastener of FIG. 17;

FIG. 19 is a perspective view with portions cut away of a fastenerassembly according to an embodiment of the invention in an early stageof deploying the fastener of FIG. 17;

FIG. 20 is a perspective view of the assembly of FIG. 19 shown with thefastener being driven in the tissue layers to be fastened;

FIG. 21 is a perspective view of the assembly of FIG. 19 shown with thefastener extending through the tissue layers to be fastened and earlypartial fastener deployment according to the invention;

FIG. 22 is a perspective view of the assembly of FIG. 19 shown with thefastener initially deployed; and

FIG. 23 is a perspective view showing the fastener of the assembly ofFIG. 19 fully deployed and securely fastening a pair of tissue layerstogether.

DETAILED DESCRIPTION

FIG. 1 is a front cross-sectional view of theesophageal-gastro-intestinal tract 40 from a lower portion of theesophagus 41 to the duodenum 42. The stomach 43 is characterized by thegreater curvature 44 on the anatomical left side and the lessercurvature 45 on the anatomical right side. The tissue of the outersurfaces of those curvatures is referred to in the art as serosa tissue.As will be seen subsequently, the nature of the serosa tissue is used toadvantage for its ability to bond to like serosa tissue. The fundus 46of the greater curvature 44 forms the superior portion of the stomach43, and traps gas and air bubbles for burping. The esophageal tract 41enters the stomach 43 at an esophageal orifice below the superiorportion of the fundus 46, forming a cardiac notch 47 and an acute anglewith respect to the fundus 46 known as the Angle of His 57. The loweresophageal sphincter (LES) 48 is a discriminating sphincter able todistinguish between burping gas, liquids, and solids, and works inconjunction with the fundus 46 to burp. The gastroesophageal flap valve(GEFV) 49 includes a moveable portion and an opposing more stationaryportion. The moveable portion of the GEFV 49 is an approximately 180degree, semicircular, gastroesophageal flap 50 (alternatively referredto as a “normal moveable flap” or “moveable flap”) formed of tissue atthe intersection between the esophagus 41 and the stomach 43. Theopposing more stationary portion of the GEFV 49 comprises a portion ofthe lesser curvature 45 of the stomach 43 adjacent to its junction withthe esophagus 41. The gastroesophageal flap 50 of the GEFV 49principally comprises tissue adjacent to the fundus 46 portion of thestomach 43, is about 4 to 5 cm long (51) at it longest portion, and thelength may taper at its anterior and posterior ends. Thegastroesophageal flap 50 is partially held against the lesser curvature45 portion of the stomach 43 by the pressure differential between thestomach 43 and the thorax, and partially by the resiliency and theanatomical structure of the GEFV 49, thus providing the valvingfunction. The GEFV 49 is similar to a flutter valve, with thegastroesophageal flap 50 being flexible and closeable against the othermore stationary side.

The esophageal tract is controlled by an upper esophageal sphincter(UES)in the neck near the mouth for swallowing, and by the LES 48 andthe GEFV 49 at the stomach. The normal anti-reflux barrier is primarilyformed by the LES 48 and the GEFV 49 acting in concert to allow food andliquid to enter the stomach, and to considerably resist reflux ofstomach contents into the esophagus 41 past the gastroesophageal tissuejunction 52. Tissue aboral of the gastroesophageal tissue junction 52 isgenerally considered part of the stomach because the tissue protectedfrom stomach acid by its own protective mechanisms. Tissue oral of thegastroesophageal junction 52 is generally considered part of theesophagus and it is not protected from injury by prolonged exposure tostomach acid. At the gastroesophageal junction 52, the juncture of thestomach and esophageal tissues form a zigzag line, which is sometimesreferred to as the “Z-line.” For the purposes of these specifications,including the claims, “stomach” means the tissue aboral of thegastroesophageal junction 52.

FIG. 2 is a front cross-sectional view of anesophageal-gastro-intestinal tract illustrating a Grade I normalappearance movable flap 50 of the GEFV 49 (shown in dashed lines) and adeteriorated Grade III gastroesophageal flap 55 of the GEFV 49 (shown insolid lines). As previously mentioned, a principal reason forregurgitation associated with GERD is the mechanical failure of thedeteriorated (or reflux appearance) gastroesophageal flap 55 of the GEFV49 to close and seal against the higher pressure in the stomach. Due toreasons including lifestyle, a Grade I normal gastroesophageal flap 50of the GEFV 49 may deteriorate into a Grade III deterioratedgastroesophageal flap 55. The anatomical results of the deteriorationinclude moving a portion of the esophagus 41 that includes thegastroesophageal junction 52 and LES 48 toward the mouth, straighteningof the cardiac notch 47, and increasing the Angle of His 57. Thiseffectively reshapes the anatomy aboral of the gastroesophageal junction52 and forms a flattened fundus 56. The deteriorated gastroesophagealflap 55 illustrates a gastroesophageal flap valve 49 and cardiac notch47 that have both significantly degraded. Dr. Hill and colleaguesdeveloped a grading system to describe the appearance of the GEFV andthe likelihood that a patient will experience chronic acid reflux. L. D.Hill, et al., The gastroesophageal flap valve: in vitro and in vivoobservations, Gastrointestinal Endoscopy 1996:44:541-547. Under Dr.Hill's grading system, the normal movable flap 50 of the GEFV 49illustrates a Grade I flap valve that is the least likely to experiencereflux. The deteriorated gastroesophageal flap 55 of the GEFV 49illustrates a Grade III (almost Grade IV) flap valve. A Grade IV flapvalve is the most likely to experience reflux. Grades II and III reflectintermediate grades of deterioration and, as in the case of III, a highlikelihood of experiencing reflux. With the deteriorated GEFVrepresented by deteriorated gastroesophageal flap 55 and the fundus 46moved inferior, the stomach contents are presented a funnel-like openingdirecting the contents into the esophagus 41 and the greatest likelihoodof experiencing reflux. Disclosed subsequently is a device for restoringthe normal gastroesophageal flap valve anatomy, which device is oneembodiment of the present invention.

Referring now to FIG. 3, it is a perspective view of a fastenerembodiment 100. The fastener 100 generally includes a first member 102,a second member 104, and a connecting member 106. As may be noted inFIG. 3, the first member 102 and second member 104 are substantiallyparallel and substantially perpendicular to the connecting member 106which connects the first member 102 to the second member 104.

The first and second members 102 and 104 are generally cylindrical. Eachhas a longitudinal axis 108 and 110 and a through channel 112 and 114along the longitudinal axes 108 and 110. The through channels 112 and114 are formed by through bores which are dimensioned to be slidinglyreceived on a tissue piercing deployment wire to be describedhereinafter.

The first member 102 also includes a first end 116 and a second end 118.Similarly, the second member 114 includes a first end 120 and a secondend 122. The first ends 116 and 120 form pointed dilation tips 124 and126, respectively. The dilation tips 124 and 126 are conical and moreparticularly take the shape of truncated cones. The pointed tips 129 and126 are pointed in opposite directions.

The first and second members 102 and 104 and the connecting 106 may beformed of different materials and have different textures. Thesematerials may include, for example, plastic materials such aspolypropylene, polyethylene, polyglvcolic acid, polyurethane, or athermoplastic elastomer. Alternatively, the fastener may be formed of ametal, such as stainless steel or a shape memory metal, such as Nitinol.As may be further noted in FIG. 3, the connecting member 106 has avertical dimension 128 and a horizontal dimension 130 which istransverse to the vertical dimension. The horizontal dimension issubstantially less than the vertical dimension to render the connectingmember 106 readily bendable in a horizontal plane. The connecting memberis further rendered bendable by the nature of the plastic material fromwhich the fastener 100 is formed. The connecting member may be formedfrom either an elastic plastic or a permanently deformable plastic. Anelastic material would prevent compression necrosis in someapplications.

Referring now to FIG. 4, it illustrates another fastener embodiment 140.As with the fastener 100 of FIG. 3, the fastener 140 includes a firstmember 142, a second member 144, and a connecting member 146. Thefastener 140 may be formed in one piece and from plastic materialsimilar to the fastener 100 of FIG. 3. The fasteners 100 and 140 may beformed of a plastic material which includes a color pigment, for examplepthalocyanine blue, for contrasting with the color of body tissue toenable visualization of the fastener with an endoscope during thedeployment of the fasteners. In addition, as may be seen in FIG. 4, thefastener 140 is impregnated with radio opaque material 148 so as torender the fastener 140 at least partially viewable under fluoroscopy.The radio opaque particles may be, for example, barium sulfate, bismuthsubcarbonate, tungsten powder or tantalum powder.

In addition to the foregoing, the second member 144 of the fastener 140includes a plurality of longitudinally spaced vertical slots 150. Thisrenders the second member 144 flexible in a direction opposite the slotsbut stiff in a direction of the slots. Hence, the second member 144 isresistant to bending in a first direction indicated by arrow 152 whilebeing substantially less resistant to bending in a direction indicatedby arrow 154. The reduced resistance to bending in the direction 154 ofthe second member 144 of the fastener 140 may be utilized to advantagein the deployment of the fastener 140.

Referring now to FIG. 5, it is a perspective view with portions cut awayof a fastener assembly embodiment 160. The tissue layer portions abovethe fastener 162 have been shown cut away in FIGS. 5-9 to enable thedeployment procedure to be seen more clearly. The assembly 160 generallyincludes a fastener 162, a deployment wire 164, a pusher 166, and aguide tube 168.

The fastener 162 takes the form of a further fastener embodiment andincludes a first member 172, a second member 174, and a connectingmember 176. The fastener 162 differs from the fasteners 100 and 140 ofFIGS. 3 and 4, respectively, in that the second member 174 is of solidconstruction and does not include a longitudinal through channel or apointed tip. However, the first member 172 includes a through channel aspreviously described and a pointed tip 178.

The first member 172 of the fastener 162 is slidingly received on thedeployment wire 164. The deployment wire 164 has a pointed tip 178 forpiercing the tissue layers 180 and 182 to be fastened together. As willbe seen hereinafter, and in accordance with further aspects of thepresent invention, the tissue layers 180 and 182 may be folded stomachtissue which are to be fastened and maintained together to form andmaintain a gastroesophageal flap valve.

As will be noted in FIG. 5, the tissue piercing wire 164, fastener 162,and the pusher 166 are all within the guide tube 168. The guide tube 168may take the form of a catheter, for example.

As will be further noted in FIG. 5, the second member 174 is disposedalong side the first member 172. This is rendered possible by theflexibility of the connecting member 176. Preferably, the first member,connecting member, and second member are arranged so that the connectingmember 176 lies to the side of the first member 172 and the secondmember 174.

With the first member 172 of the fastener 162 slidingly received on thetissue piercing wire 164 and with the pusher 166 just touching the firstmember 172 on the tissue piercing wire 164, the tip 178 of the tissuepiercing wire 164 pierces the tissue layers 180 and 182. The subassemblyof the tissue piercing wire 164, fastener 162, and pusher 166 may beguided to its intended location relative to the tissue layers 180 and182 by the guide tube 168. As will be seen hereinafter, this subassemblymay be alternatively guided by guide channels arranged to accommodatethe tissue piercing wire 164, fastener 162, pusher 166, and the guidetube 168.

Once the tissue piercing wire 164 has pierced the tissue layers 180 and182 to be fastened together, the pusher 166 may be utilized to push thefirst member 172 of the fastener 162 through the tissue layers 180 and182 on the tissue piercing wire 164. This is illustrated in FIG. 6. Asthe pusher 166 pushes the first member 172 through the tissue layers 180and 182, the connecting member 176 follows along beside and immediatelyadjacent to the first member 172 of the fastener 162 and the pusher 166.As may be seen in FIG. 7, the pusher 166 continues to push the firstmember 172 of the fastener 162 through the tissue layers 180 and 182 onthe tissue piercing wire 164 until the end 173 of the first member 172engaging the pusher 166 clears the second tissue layer 182. It may alsobe noted that at this time, the second member 174 of the fastener 162has engaged the surface 181 of tissue layer 180.

Referring now to FIG. 8, it will be seen that once the end 173 of thefirst member 172 has cleared the tissue layer 182, the tissue piercingwire 164 is then retracted within the pusher 166 to release the firstmember 172. The first member 172 being thus released from the tissuepiercing wire 164 will return to its original configurationsubstantially parallel to the second member 174 and substantiallyperpendicular to the connecting member 176. When the first member 172 isdeployed as shown in FIG. 8, the tissue piercing wire 164 and pusher 166may be withdrawn.

FIG. 9 illustrates the fastener 162 in its deployed position. It will benoted that the tissue layers 180 and 182 are fastened together betweenthe first member 172 of the fastener 162 and the second member 174 ofthe fastener 162. The connecting member 176 extends through the tissuelayers 180 and 182.

FIG. 10 is a perspective view with portions cut away of another fastenerand fastener assembly embodiment. The fastener 190 of FIG. 10 includes afirst member 192, a second member 194, and a connecting member 196. Thefastener 190 is similar to the fastener 100 of FIG. 3 in that both thefirst member 192 and second member 194 includes a through bore. Thispermits the first member 192 and second member 194 to be slidinglyreceived in line with each other on the tissue piercing wire 164. Withboth the first member 192 and second member 194 being disposed on thetissue piercing wire 164, the second member 194 will not be deployeduntil after the tissue piercing wire 164 is retracted from the secondmember 194. As a result, the second member of the fastener 162illustrated in FIGS. 5-9 will deploy before the second member 194 offastener 190. However, the arrangement illustrated in FIG. 10 may beadvantageous where space is at a premium and the guide tube 168 has areduced diameter. The deployment of the fastener 190 by the tissuepiercing wire 164, the pusher 166, and the guide tube 168 is otherwisesimilar to the deployment procedure described above with respect toFIGS. 5-9.

FIG. 11 shows another fastener embodiment 200. The fastener 200 isillustrated in an initial stage of deployment by the tissue piercingdeployment wire 164, the pusher 166, and the guide tube 168 to fastentissue layers 180 and 182 together. FIG. 12 shows the fastener 200 afterdeployment fastening tissue layers 180 and 182 together. The fastener200 may be deployed as previously described in connection with FIGS.5-9.

The fastener 200 includes a first member 202, a second member 204, and aconnecting member 206. The connecting member 206 takes the form of abeaded chain and the second member is bifurcated at 208 to permit thesecond member 204 to be positioned between any pair of beads of theconnecting member 204. This renders the length of the connecting member206 between the first and second members 202 and 204 adjustable toaccommodate tissue layers of various densities and thicknesses.

Referring now to FIGS. 13 and 14, they illustrate still another fastener600. The fastener 600 generally includes a first member 602, a secondmember 604, and a connecting member structure 606. As may be noted inFIGS. 13 and 14 the connecting member structure includes a plurality ofconnecting members 608 and 610. The connecting members 608 and 610connect the first member 602 to the second member 604.

The first member 602 is cylindrical and the second member 604 is acylindrical half-section. Each has a longitudinal through channel 612and 614. The through channel 614 is a through bore which is dimensionedto be a slidingly received on a tissue piercing deployment wire. Thechannel 614 is dimensioned to be optionally carried on the deploymentwire prior to deployment. The first member 602 also includes a conicalpointed tip 614.

The fastener 600 may be formed of any of the plastic or metal materialspreviously described. As may be further noted in FIGS. 13 and 14 theconnecting members 600 and 610 are relatively thin to render theconnecting member structure 606 readily bendable for ease of deployment.The connecting member structure is further rendered bendable of courseby the nature of the plastic or metal material from which the fastener600 is formed.

Referring now to FIGS. 15 and 16, they illustrate another fastenerembodiment 700. As with the previous fastener, the fastener 700 includesa cylindrical first member 702, cylindrical half-section 704 and aconnecting member structure 706. The connecting member structure 706includes connecting members 708 and 710. Here however, the pointed tip714 takes the form of a tapered section of the first member 702.

As in the previous embodiment the first member 702 of the fastener 700may be slidingly received on a deployment wire. The deployment wire maybe received by a bore 712. The fasteners 600 and 700 may be deployed aspreviously described.

Referring now to FIG. 17, it is a perspective view of a fastener 1100according to an embodiment of the invention. The fastener 1100 generallyincludes a first member 1102, a second member 1104, and a connectingmember 1106. As may be noted in FIG. 17, the first member 1102 andsecond member 1104 are substantially parallel and substantiallyperpendicular to the connecting member 1106 which connects the firstmember 1102 to the second member 1104.

The first member 1102 is generally cylindrical. It has a longitudinalaxis 1108 and a through channel 1112 along the longitudinal axes 1108.The through channel 1112 is formed by a through bore which isdimensioned to be slidingly received on a tissue piercing deploymentwire as previously described.

The first member 1102 also includes a first end 1116 and a second end1118. Similarly, the second member 1104 includes a first end 1120 and asecond end 1122. The first end 1116 of member 1102 forms a pointeddilation tip 1124. The dilation tip 1124 is conical and moreparticularly takes the shape of a truncated cone.

The first and second members 102 and 104 and the connecting 106 may beformed of the various materials previously described. As may be furthernoted in FIG. 17, the connecting member 1106 has a horizontal dimensionthat is substantially less than its vertical dimension to render theconnecting member 1106 readily bendable in a horizontal plane. Theconnecting member is further rendered bendable by the nature of theplastic material from which the fastener 1100 may be formed.

FIG. 18 illustrates a side view of the fastener 1100. Here, it will benoted that the 1102 including an elongated slot 1126. The slot 1126 hasa transverse dimension for receiving the tissue piercing deployment wireduring deployment of the fastener 1100. As will be seen subsequently,this permits early deployment of the first member 1102 and decreasescompression on the tissue layers. The elongated slot 1126 extendssubstantially parallel to the through channel 1112 and the center axis1108 of the first member 1102.

Referring now to FIG. 19, it is a perspective view with portions cutaway of a fastener assembly 1200 embodying the present invention fordeploying the fastener 1100. The tissue layer portions above thefastener 1100 have been shown cut away in FIGS. 19-22 to enable thedeployment procedure to be seen more clearly. The assembly 1200generally includes the fastener 1100, the deployment wire 164, thepusher 166, and the guide tube 168.

The first member 1102 of the fastener 1100 is slidingly received on thedeployment wire 164. The deployment wire 164 has a pointed tip 178 forpiercing the tissue layers 180 and 182 to be fastened together. Thetissue piercing wire 164, fastener 1100, and the pusher 166 are allwithin the guide tube 168. The guide tube 168 may take the form of acatheter, for example, as previously mentioned.

As will be further noted in FIG. 19, the second member 1104 is disposedalong side the first member 1102. This is rendered possible by theflexibility of the connecting member 1106.

With the first member 1102 of the fastener 1100 slidingly received onthe tissue piercing wire 164 and with the pusher 166 just touching thefirst member 1102 on the tissue piercing wire 164, the tip 178 of thetissue piercing wire 164 pierces the tissue layers 180 and 182. Thesubassembly of the tissue piercing wire 164, fastener 1100, and pusher166 may be guided to its intended location relative to the tissue layers180 and 182 by the guide tube 168.

Once the tissue piercing wire 164 has pierced the tissue layers 180 and182 to be fastened together, the pusher 166 may be utilized to push thefirst member 1102 of the fastener 1100 through the tissue layers 180 and182 on the tissue piercing wire 164. This is illustrated in FIG. 20. Asthe pusher 166 pushes the first member 1102 through the tissue layers180 and 182, the connecting member 1106 follows along beside andimmediately adjacent to the first member 1102 of the fastener 1100 andthe pusher 166.

As may be seen in FIG. 21, when the second member engages tissue layer180, the pusher 166 may be retracked within the first member 1102 of thefastener 1100. The tissue piercing wire 164 is received within theelongated slot 1126 to permit the tissue piercing wire 164 to releasethe first member 1102 for early deployment. The second end 1118 of thefirst member 1102 now clears the second tissue layer 182. This earlyrelease of the first member 1102 reduces the compression on the tissuelayers 180 and 182 even though the second member 1104 has engaged thetissue layer 180.

Referring now to FIG. 22, it will be seen that once the second end 1118of the first member 1102 has cleared the tissue layer 182, the tissuepiercing wire 164 is then retracted into the pusher 166 to fully releasethe first member 1102. The first member 1102 being thus fully releasedfrom the tissue piercing wire 164 will return to its originalconfiguration substantially parallel to the second member 1104 andsubstantially perpendicular to the connecting member 1106. When thefirst member 1102 is deployed as shown in FIG. 22, the tissue piercingwire 164 and pusher 166 may be withdrawn.

FIG. 23 illustrates the fastener 1100 in its fully deployed position. Itwill be noted that the tissue layers 180 and 182 are fastened togetherbetween the first member 1102 of the fastener 1100 and the second member1104 of the fastener 1100. The connecting member 1106 extends throughthe tissue layers 180 and 182.

While particular embodiments of the present invention have been shownand described, modifications may be made, and it is therefore intendedin the appended claims to cover all such changes and modifications whichfall within the true spirit and scope of the invention.

What is claimed is:
 1. A fastener for use in a mammalian body,comprising: a first member; a second member, both the first and secondmembers having first and second ends; and a connecting member fixed toeach of the first and second members intermediate the first and secondends and extending between the first and second members, the first andsecond members being separated by the connecting member, and one of thefirst and second members having a longitudinal axis, a through channelalong the axis arranged to be slidingly received on a tissue piercingdeployment wire, and an elongated slot which is substantially parallelto the through channel and communicating with the through channel anddimensioned to receive the tissue piercing deployment wire.
 2. Thefastener of claim 1 wherein the connecting member is flexible andpermits another one of the first and second members to be next to theone of the first and second members when the one of the first and secondmembers is on the tissue piercing deployment wire.
 3. The fastener ofclaim 1 wherein one end of the one of the first and second membersfurther includes a pointed tip.
 4. The fastener of claim 3 wherein thepointed tip is conical.
 5. The fastener of claim 3 wherein the pointedtip comprises a sectioned portion.
 6. The fastener of claim 1 whereinthe through channel comprises a through bore.
 7. The fastener of claim 1wherein the connecting member is formed of elastic material.
 8. Thefastener of claim 1 wherein the first member, the second member, and theconnecting member are all formed of plastic material.
 9. The fastener ofclaim 8 wherein the first member, the second member, and the connectingmember are all formed in one piece.
 10. The fastener of claim 8 whereinthe connecting member is formed of plastic elastic material.
 11. Thefastener of claim 8 wherein the connecting member is formed of aplastic, permanently deformable material.
 12. The fastener of claim 8wherein the plastic material includes a color pigment contrasting withbody tissue color to enable visualization of the fastener with anendoscope.
 13. The fastener of claim 1 wherein the first and secondmembers and the connecting member are formed of different materials. 14.The fastener of claim 1 wherein the fastener is formed of metal.
 15. Thefastener of claim 14 wherein the metal is a shape memory material. 16.The fastener of claim 15 wherein the metal is Nitinol.